NervGen Pharma Announces Third Quarter Financial Results and Corporate Update

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11/24/2025 – 07:05 AM

• Expanded CONNECT SCI Study data demonstrated unprecedented durable improvement in function, independence, and quality of life in individuals living with chronic spinal cord injury
• Completed a U.S. Food and Drug Administration (FDA) Type C meeting in September; FDA confirmed that multiple regulatory routes are available to support approval of NVG-291 as the first pharmacologic treatment for spinal cord injury
• Completed a US$10 million non-brokered private placement to support an anticipated Nasdaq listing, with participation from both long standing and new mission-driven investors, including SCI Ventures
• NVG-291-R demonstrated statistically significant functional recovery in U.S. Department of Defense sponsored preclinical models of traumatic hearing loss and peripheral nerve injury, reinforcing NVG-291’s broad therapeutic potential

Vancouver, British Columbia–NervGen Pharma Corp. (TSXV: NGEN) (OTCQB: NGENF) (“NervGen” or the “Company”), a clinical-stage biopharmaceutical company developing first-in-class neuroreparative therapeutics for spinal cord injury (SCI) and other traumatic and neurologic disorders, today announced financial results and provided business updates for the third quarter ended September 30, 2025.

Adam Rogers, MD, Interim Chief Executive Officer at NervGen Pharma, stated, “The third quarter represented a continuation of the historic momentum we first articulated in our second quarter shareholder letter. I can now state with confidence that the expanded CONNECT SCI Study data we reported today further strengthens and reinforces our conviction in NVG-291. NVG-291 continues to demonstrate the ability to restore clinically meaningful function and drive real-world improvements in independence and quality of life, even well beyond the 12-week treatment period. CONNECT SCI Study participants treated with NVG-291 reported durable improvements in both upper and lower body function, as well as across key quality of life domains, including strengthened bladder control and reduced muscle spasticity. These sustained and continuing clinical gains are supported by compelling neurophysiological evidence, including statistically significant reductions of hyperactive reticulospinal signaling in the upper and lower limbs, establishing the biological basis for NVG-291’s clinical efficacy.”

“Moving forward, our focus remains clear: advance NVG-291 with urgency and in close collaboration with the SCI community and the FDA. We are deeply encouraged by the progress achieved this quarter and remain steadfast in our mission to transform the lives of individuals living with SCI.”

Pipeline Progress
Today, we announced expanded CONNECT SCI Study data. NVG-291 continues to demonstrate the ability to restore clinically meaningful function and drive real-world improvements in independence and quality of life, including notable improvements in bladder control and reduced muscle spasticity. At Week 16, four weeks after the end of daily, subcutaneous NVG-291 treatment, participants demonstrated durable and continuing functional improvements, as exhibited by a 2.6-fold greater mean improvement in GRASSP Total Score and a 3.7-fold greater mean improvement in GRASSP Quantitative Prehension compared to placebo.

CONNECT SCI Study participants were assessed up to 364 days after the conclusion of the study period via blinded, institutional review board (IRB) approved qualitative exit interviews. Participants dosed with NVG-291 reported greater overall improvement compared to placebo, as measured by the participant impression of global change (PGIC), with 75% (6/8) of NVG-291 participants reporting “much” or “very much” improved symptoms compared to 33% (3/9) on placebo. NVG-291 participants were also more likely than placebo to report sustained improvements across key quality of life domains, including reduced reliance on medications or mobility aids, and greater physical activity tolerance. Furthermore, 67% (6/9) of NVG-291 participants reported improved bladder control compared to 22% (2/9) on placebo and 56% (5/9) of NVG-291 participants reported reduced muscle spasticity compared to 22% (2/9) on placebo. The biological basis for NVG-291’s clinical efficacy is supported by statistically significant reductions of hyperactive reticulospinal signaling in the upper and lower limbs, as measured by startle motor evoked potential (MEP), and the statistically significant improvement of upper-body corticospinal signaling, as measured by MEP.

Regulatory Progress
Today, we announced that the Company completed an FDA Type C meeting in September to discuss clinical development plans and the potential for accelerated approval. The FDA confirmed that multiple regulatory pathways are available to support approval, given the significant unmet medical need among individuals living with SCI and the lack of any approved pharmacologic treatments. The Company anticipates an End-of-Phase 2 meeting in early 2026 to further align with the FDA on the development and registration pathway for NVG-291.

Financial Progress
On November 19, 2025, we completed a non-brokered Private Placement of 4,785,674 units of the Company at a price of US$2.10 per Unit for aggregate gross proceeds of US$10,049,915 to certain institutional investors and other accredited investors. The financing included participation from new and existing investors, including SCI Ventures and the Paul and Phyllis Fireman Charitable Foundation. Each Unit consisted of one Common Share and one-half of one Common Share purchase warrant (each whole warrant, a “Warrant”). The Warrants are valid for 36 months and each Warrant is exercisable into one Common Share at an exercise price of US$2.65.

Corporate Progress
In July 2025, we strengthened our senior leadership to ensure execution of NervGen’s mission and position the Company for late-stage development of NVG-291. Adam Rogers, MD, was appointed Interim Chief Executive Officer and Randall Kaye, MD, as Chief Medical Advisor:

• Adam Rogers, MD, Chairman and largest shareholder, is a board-certified physician and seasoned biotech executive. He most recently served as founder and CEO of Hemera Biosciences for more than a decade until its acquisition by Janssen Pharmaceuticals, Inc.
• Randall Kaye, MD, brings over 30 years of medical expertise and extensive clinical development experience in central nervous system conditions and disorders. He most recently served as Chief Medical Officer of Longboard Pharmaceuticals, where he helped guide the company through its $2.6 billion acquisition by H. Lundbeck A/S.

Financial Results

Cash and Investments: NervGen had cash and investments of $11.4 million as of September 30, 2025, which does not include the proceeds from the non-brokered private placement completed on November 19, 2025, compared to $17.3 million as of December 31, 2024. The decrease is due to operating activities related to the ongoing CONNECT SCI Study, which were partially offset by proceeds from warrant and option exercises in the current year. The Company did not issue any shares under its at-the-market (ATM) equity program in the quarter ended September 30, 2025; no additional shares have been issued under the ATM program since the quarter ended September 30, 2025.

Research & Development (R&D) Expenses: R&D expenses were $4.4 million for the three months ended September 30, 2025, compared to $4.4 million in the same period in 2024. The current period included higher costs related to procuring drug supply for future NVG-291 clinical trials, the ongoing expanded access program (EAP), and other regulatory requirements. Clinical and regulatory costs were lower in the current period primarily due to the completion of the chronic cohort of the CONNECT SCI Study during the previous quarter. Preclinical development costs were lower in the quarter as company resources continued to be concentrated on NVG-291 manufacturing and clinical development. Non-cash stock-based compensation increased in the quarter as a result of the valuation of more recently granted options.

General and Administrative (G&A) Expenses: G&A expenses were $1.7 million for the three months ended September 30, 2025, compared to $2.8 million for the same period in 2024. The decrease in the three months ended September 30, 2025, is primarily related to reduced non-cash stock-based compensation resulting from changes in personnel, as well as lower legal and professional expenses than the previous quarter, as the company focused its resources towards the development of NVG-291.

Net Loss: For the three months ended September 30, 2025, net loss was $4.2 million, or $0.06 per basic and diluted common share. The net loss for the quarter included $1.2 million of non-cash expenses pertaining to amortization, stock-based compensation, unrealized foreign exchange and a $2.0 million non-cash gain due to the fair value adjustment of the warrant derivative. For the three months ended September 30, 2024, net loss was $5.3 million, or $0.08 per basic and diluted common share which included $1.8 million of net non-cash expenses pertaining to amortization, stock-based compensation, unrealized foreign exchange gain on cash and a $1.8 million non-cash gain due to the fair value adjustment of the warrant derivative.

About NVG-291
NervGen holds exclusive worldwide rights to NVG-291, a first- and potential best-in-class therapeutic peptide enabling the nervous system to repair itself. NVG-291’s technology is licensed from Case Western Reserve University and is based on academic studies that demonstrated the preclinical efficacy of NVG-291-R, the rodent variant of NVG-291, in animal models of spinal cord injury. These studies implicated multiple potential molecular and cellular mechanisms by which NVG-291-R promotes neurorepair and functional improvement in both central and peripheral nervous system injury models. The implicated mechanisms include the promotion of neuronal sprouting, or plasticity, remyelination, and promotion of a non-inflammatory phenotype in the microglial cells. NervGen has received Fast Track designation from the FDA and Orphan Designation from the EMA for NVG-291 in individuals with spinal cord injury.

About NervGen
NervGen Pharma Corp. (TSXV: NGEN) (OTCQB: NGENF) is a clinical-stage biopharmaceutical company dedicated to developing innovative therapies that enable the nervous system to repair itself in settings of neurotrauma and neurologic disease. The Company is evaluating the clinical efficacy of its lead candidate, NVG-291, in the Phase 1b/2a CONNECT SCI Study in spinal cord injury. The company’s approach targets the underlying mechanisms of nerve damage, offering a potential paradigm shift in the treatment of these conditions. The recent private placement, while introducing potential dilution, provides runway for NervGen to advance NVG-291 through critical regulatory milestones, including the anticipated End-of-Phase 2 meeting with the FDA. The company’s cash burn remains a concern, requiring careful management of resources to maximize the value of its pipeline. Investors will be closely watching for further clinical data readouts and regulatory updates in the coming quarters.

What did NervGen (NGENF) announce about the CONNECT SCI Study on November 24, 2025?

Expanded CONNECT SCI data showed durable functional gains with NVG-291, including a 2.6-fold greater GRASSP Total improvement and 3.7-fold greater Quantitative Prehension versus placebo at Week 16.

How did patients report global improvement in NervGen’s CONNECT SCI Study (NGENF)?

Participant impression of global change (PGIC) showed 75% of NVG-291 participants reported ‘much’ or ‘very much’ improved versus 33% for placebo.

What regulatory progress did NervGen (NGENF) report regarding NVG-291 in Q3 2025?

NervGen completed an FDA Type C meeting; the FDA confirmed multiple regulatory pathways and an End-of-Phase 2 meeting is expected in early 2026.

How much financing did NervGen (NGENF) raise on Nov 19, 2025 and what were the terms?

NervGen completed a non-brokered private placement raising US$10.05M via 4,785,674 units at US$2.10 per unit; each unit included one share and one-half warrant exercisable at US$2.65 for 36 months.

What was NervGen’s cash position at Sept 30, 2025 and why is it material to investors?

Cash and investments were $11.4M at Sept 30, 2025 (pre-proceeds of Nov 19 financing), down from $17.3M at Dec 31, 2024, reflecting operating spend on CONNECT SCI.

Did NervGen (NGENF) report preclinical or additional pipeline data in Q3 2025?

Yes; NVG-291-R showed statistically significant functional recovery in DoD-sponsored preclinical models of traumatic hearing loss and peripheral nerve injury, supporting broader therapeutic potential.